when children may be reluctant to distress their parents by voicing disagreement. The federal regulations specify that failure to object to participation should not, by itself, be construed as assent. Again, in the committee’s view, a child’s dissent does not preclude investigators seeking the child’s assent at another time, as long as such practices are respectful and not coercive and parents are involved and supportive.

Some research has the potential to reveal sensitive information about a child or, more often, an adolescent that might provoke negative, even punitive, parental reactions. Investigators should be sensitive to this potential and should determine when adolescents and possibly younger children should be told about the kinds of information that may be shared with their parents if they agree to participate in research. Researchers studying adolescents have been concerned that the federal privacy regulations (see Appendix C) may allow parents to have access to information about adolescents that would otherwise be held confidential. The regulations defer to state laws on parental access to the health records of minors, which means that research-related personal information may be protected in some states and not in others.

Recommendation 5.6: In designing and reviewing procedures for seeking a child’s assent to participation in research, investigators and institutional review boards should aim to create assent processes that consider and respect the child and the family as a unit as well as individually. The process for requesting assent should

  • be developmentally appropriate given the ages and other characteristics of the children to be approached;

  • provide opportunities for children to express and discuss their willingness or unwillingness to participate;

  • clarify for parents and children (as appropriate) the degree of control that each will have over the participation decision; and

  • when appropriate, describe to children and parents the kinds of information about the child that will or will not be shared with the parents.

Age-Appropriate Assent Processes

The construction of age-appropriate assent materials and procedures should be informed by the literature on cognitive development in general and on child and adolescent capacities for assent in particular. For children and adolescents at all ages, the assent process should be designed to be an empowering and respectful experience.

The research on children’s cognitive, intellectual, social, and emotional development and their understanding of research participation provides

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